Regulatory Focus™ > News Articles > Four Former Executives Barred from Federal Programs for Unauthorized Human Testing

Four Former Executives Barred from Federal Programs for Unauthorized Human Testing

Posted 11 October 2012 | By Alexander Gaffney, RAC 

Four executives once associated with bone product and medical device manufacturer Synthes will be barred from participating in any federal healthcare program after serving prison time for what prosecutors said was a disregard for patient safety, federal health officials have announced.

The four-Michael Huggins, formerly COO; John Walsh, director of regulatory affairs; Thomas Higgins, president of Synthes' spine division; and Richard Bohner, VP of operations-were sentenced to prison in 2011 for between five and nine months each after being convicted of running unauthorized clinical trials for an unapproved bone cement product.

(For Background, read Fortune Magazine's, "Bad to the Bone: A Medical Horror Story.")

All four will be barred under Section 1128(b)(1) of the Social Security Act, which provides for a minimum suspension of at least three years, but does not provide for a maximum suspension. The US Food and Drug Administration (FDA) often makes its own subsequent determination as to the total time an individual should be barred from participating in federal programs, including those overseen by FDA regulatory authorities.

FDA's process of debarment is based on an advance notice, which may be subject to appeal if the individual believes it is unfair relative to the convicted crime. In severalcases where people were arguably convicted of less severe crimes than the Synthes executives were, FDA established permanent bans on the individuals serving in any capacity for a company with a pending or approved drug product. The Synthes executives may therefore find themselves unable to ever serve in the industry again.

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